Global UDI Program Lead - Regulatory & Data Quality

Antler; Loughbeg; On-site; EUR 102,000 - 175,000; Full time

Benefits offered by this job

Vacation 120hrs

Sick leave 40hrs

Holiday pay

Parental leave

Volunteer leave

Job summary

DePuy Synthes is seeking a Manager, Global UDI to lead global UDI governance across the orthopedic portfolio. You will ensure data integrity, regulatory readiness, and system compliance in collaboration with Regulatory Affairs, IT, Supply Chain, R&D, and Commercial teams.

This role offers cross‑border impact, supporting patient safety and product traceability while shaping scalable UDI processes and systems for multiple markets, including Ireland and the U.S.

Qualifications

• 6–8 years of relevant experience in Quality Assurance, Regulatory Compliance, or Technology Quality within a regulated industry.
• Demonstrated experience with UDI regulations and global regulatory frameworks (e.g., FDA, EU MDR).
• Strong knowledge of quality systems, data governance, and computerized system validation.
• Proven ability to lead cross‑functional, global initiatives in a matrixed organization.
• Experience supporting audits and regulatory inspections.
• Strong analytical, problem‑solving, and risk‑based decision‑making skills.
• Excellent written and verbal communication skills.

Responsibilities

• Lead and govern the global UDI program, ensuring compliance with FDA, EU MDR, and other applicable international UDI regulations.
• Own UDI‑related quality processes, procedures, and controls, ensuring alignment with standards.
• Partner with IT and digital teams to ensure UDI system design, validation, data integrity, and ongoing system compliance.
• Provide quality oversight for UDI data management, including master data accuracy, change control, and issue remediation.
• Lead cross‑functional collaboration with Regulatory Affairs, Supply Chain, Manufacturing, R&D, and Commercial teams to ensure end‑to‑end UDI execution.
• Support and participate in regulatory inspections, internal audits, and health authority interactions related to UDI compliance.
• Monitor global regulatory trends and translate new or evolving UDI requirements into scalable business and quality processes.
• Drive continuous improvement initiatives to enhance UDI governance, efficiency, and compliance sustainability.
• Provide coaching and leadership to team members and stakeholders to strengthen UDI and quality capabilities across the organization.

Skills

UDI regulations knowledge

Regulatory compliance

Quality systems

Cross-functional leadership

Audits & inspections

Analytical thinking

Communication

Education

Bachelor’s degree in Engineering, Life Sciences, Information Systems

Master’s degree preferred

Tools

ERP systems

PLM and labeling systems

Job description

DePuy Synthes is seeking a Manager, Global UDI to lead global UDI governance across the orthopedic portfolio. You will ensure data integrity, regulatory readiness, and system compliance in collaboration with Regulatory Affairs, IT, Supply Chain, R&D, and Commercial teams.

This role offers cross‑border impact, supporting patient safety and product traceability while shaping scalable UDI processes and systems for multiple markets, including Ireland and the U.S.